| Trial ID: | L6715 |
| Source ID: | NCT01536028
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 50|DRUG: biphasic insulin aspart 70|DRUG: insulin aspart
|
| Outcome Measures: |
Primary: Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing | Secondary: Maximum GIR value|Time to maximum GIR value|Area under the GIR-curves|Maximum drug concentration for insulin aspart (IAsp)|Time to maximum IAsp concentration|Area under the curve of the IAsp profiles|Minimum drug concentration in NEFA (Nonesterified fatty acids)|Time to minimum plasma concentration, NEFA|Area under the curve of the NEFA profiles|Adverse events|Hypoglycaemic episodes
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-04
|
| Completion Date: |
2006-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-06
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01536028
|
